74
Participants
Start Date
September 20, 2016
Primary Completion Date
October 26, 2018
Study Completion Date
October 26, 2018
Ibrutinib
Ibrutinib 840 mg orally, once daily continuously starting day 1 of cycle 1 until confirmed disease progression, unacceptable toxicity or other protocol specified reason for discontinuation
Bortezomib
Cycles 1-8: (21-day cycle): Bortezomib 1.3 mg/m\^2 sub-cutaneously on days 1, 4, 8, and 11 of each Cycle Cycles 9-12: (42-day cycle): Bortezomib 1.3 mg/m\^2 sub-cutaneously on days 1, 8, 22 and 29 of each Cycle
Dexamethasone
"Cycles 1-8: (21-day cycle): Dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11 and 12 of each cycle Cycles 9-12: (42-day cycle): Dexamethasone 20 mg orally on days 1, 2, 8, 9, 22, 23, 29 and 30 of each cycle Cycles 13+ (28-day cycle): Dexamethasone 40 mg orally once weekly~Dose adjustment of dexamethasone to 10 mg on days specified during cycles 1-12 and 20 mg weekly during cycles 13+ is recommended for subjects \>75 years of age.~Following implementation of Protocol Amendment 4, dexamethasone administration was reduced to Days 1, 4, 8 and 11 during each 21-day cycle (Cycles 1-8) and on Days 1, 8, 22, 29 on each 42-day cycle (Cycles 9-12) and unchanged thereafter."
Fakultní nemocnice Brno, Brno
Fakultní nemocnice Hradec Králové, Nový Hradec Králové
Fakultní nemocnice Ostrava, Ostrava-Poruba
Všeobecná fakultní nemocnice v Praha, Prague
Helios-Kliniken Berlin-Buch, Berlin
Vivantes Klinikum Spandau, Berlin
Universitätsklinikum Jena, Jena
Klinikum der Universität München Campus Grosshadern, München
251 General Air Force Hospital, Athens
"General Hospital of Athens Alexandra", Athens
"General Hospital of Athens Evangelismos", Athens
"General Hospital of Athens LAIKO", Athens
University General Hospital of Patra, Pátrai
"General Hospital of Thessaloniki G. Papanikolau", Thessaloniki
IRCCS Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi, Bologna
Istituto Scientifico Romagnolo Per lo Studio e la Cura dei Tumori, Meldola (FC)
Ospedale Santa Maria delle Croci, Ravenna
Ospedale degli Infermi, Rimini
Azienda Ospedaliera S. Maria di Terni, Terni
Hospital Universitario Rey Juan Carlos, Móstoles
Complejo Hospitalario Universitario A Coruña, A Coruña
ICO Badalona-Hospital Germans Trias i Pujol, Badalona
Hospital Clínic i Provincial de Barcelona, Barcelona
Hospital Universitario Madrid Sanchinarro, Madrid
Clinica Universidad de Navarra, Pamplona
Hospital Universitario de Salamanca, Salamanca
Hospital Universitario Virgen del Rocio, Seville
Hospital Universitario Dr. Peset, Valencia
Ankara University Medical Faculty, Ankara
Dokuz Eylul University Medicine Faculty, Izmir
Erciyes University Medical Faculty, Kayseri
Ondokuz Mayis Univ. Med. Fac., Samsun
Janssen Research & Development, LLC
INDUSTRY
Pharmacyclics Switzerland GmbH
INDUSTRY